1 Objective: Over the past 5 years, the interest in alternative therapies for menopause has increased dramatically due to the findings of the Women's Health Initiative (U.S. National Institutes of Health).
2 Menoprogen, a traditional Chinese medicine formulation is an herbal remedy that has been used in China for the management of menopause-related symptoms.
3 An observational pilot study was performed to assess the effects of Menoprogen in the management of menopausal symptoms in perimenopausal and postmenopausal women.
4 Design, subjects, and setting: A multicenter prospective study was conducted at four clinical centers in China.
5 Female subjects were eligible if they had menopausal diagnosis for at least 3 months and wished to use an alternative to hormone replacement therapy (HRT).
6 Intervention: Subjects received two capsules of Menoprogen (a combination product containing 0.2 g extracts of five herbs per capsule) orally, twice daily.
7 Main outcome measures: The primary outcome measured was an improvement of Kupperman Menopausal Index (KMI) from baseline.
8 Secondary outcomes measured included hormone levels and the status of the endometrial and vaginal cytology after completion of treatment. Results: After treatment with Menoprogen, a significant reduction in the KMI was observed (mean of paired difference = -14.875; p < 0.01) as compared with baseline.
9 Endogenous estrogen levels were significantly increased with Menoprogen (mean of paired difference = -3.145; p < 0.01).
10 Progesterone levels increased with Menoprogen (mean of paired difference = -10.003; p < 0.01).
11 Both follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels showed significant before-and-after treatment difference (mean of paired difference = 6.125 mIU/mL for FSH and 4.938 mIU/mL for LH; p < 0.01).
12 No significant endometrial hyperplasia was observed post-treatment with Menoprogen.
13 Most of the postmenopausal women exhibited a vaginal cell proliferation degree of 2-3, suggesting a possible estrogenic effect. 14 Conclusions: The present pilot study found that Menoprogen reduced symptoms associated with perimenopausal and postmenopausal complaints. Therefore, the rationale for a randomized, placebo-controlled clinical trial is supported